Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1082-2017·Announced 2017-02-01

Atrium Medical Recalls Ocean Blood Recovery Drains Due to Sterility Issues

Atrium Medical is recalling Ocean Blood Recovery Drains because the outer packaging is not sterile. The recall affects units worldwide with expiration dates prior to October 2019.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a packaging sterility issue, which fits the criteria for a moderate severity recall involving low-risk contamination or labeling/packaging errors without reported harm.

Plain-English summary

Atrium Medical Corporation is recalling specific models of Ocean Blood Recovery Drains, including catalog numbers 2050-000, 2050-300, 2052-000, and 2052-300. These medical devices are used to evacuate air and fluid from the chest cavity or mediastinum, help re-establish lung expansion, and facilitate the collection and reinfusion of autologous blood. The recall is being conducted because the outer packaging of these devices is not sterile.

The recall covers approximately 964,463 cases in the United States and 521,975 cases outside the US. The affected products were distributed worldwide, including in the US and numerous international markets such as Australia, Canada, China, France, Germany, and the United Kingdom. The recall applies to all lot numbers with an expiration date prior to October 2019.

Healthcare facilities and consumers should stop using the affected Ocean Blood Recovery Drains immediately. Atrium Medical is the recalling firm responsible for managing this Class II recall. Users should contact the manufacturer for further instructions on how to return or dispose of the affected units.

The recalled product

Product: Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain with in-line connector and suction control stopcock 2050-300 Ocean Blood Recovery drain with suction control stopcock, no in-line connector 2052-000 Ocean Double Blood Recovery drain…
Manufacturer: Atrium Medical Corporation
Category: Medical Device — Surgical Drains
Hazard: sterility
packaging-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All Lot Numbers With Expiration Date Prior To October 2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Atrium Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

Same manufacturer · Atrium Medical Corporation

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